- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00221221
Physical Activity Promotion in Breast Cancer Survivors
Physical Activity Promotion in Breast Cancer Survivors: A Population Based Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Approximately 300 breast cancer survivors living in Northern Alberta will be randomized to one of four groups: (1) an exercise recommendation only group (viewed as the current standard of care), (2) an exercise recommendation plus pedometer group, (3) an exercise recommendation plus printed materials group, and (4) an exercise recommendation plus pedometer and printed materials group. Our primary hypothesis is that participants in the three intervention groups will report a greater positive change in physical activity than participants in the exercise recommendation only group. Furthermore, we expect that participants receiving the combined pedometer and printed materials intervention will report the greatest change in physical activity. Our secondary hypotheses are that these interventions will also result in improved QoL and more positive social cognitive beliefs about exercise in breast cancer survivors. Our sample size was determined by a power calculation. Based on the literature, we believe that an increase of 2,000 steps per day is a meaningful change that will result in health benefits for breast cancer survivors. We estimate a standard deviation of about 4,000 steps per day. Therefore, to detect a medium standardized effect (d = .50) with a power of .80 and a two-tailed alpha <.05, we need 63 participants per group. To account for a possible 15% loss to follow up, we will randomize 75 participants to each group. Our printed materials will be developed based on the tenets of the theory of planned behavior and will include activities designed to enhance instrumental and affective attitudes, injunctive and descriptive norms, and self-efficacy and perceptions of control. These materials will be developed based on our previous research identifying the key beliefs that should be targeted in a theory of planned behavior-based intervention.
Our procedure will be to identify and screen potential participants for eligibility through the Alberta Cancer Registry. After obtaining written informed consent from the individual's treating oncologist, all eligible participants will be sent a letter of invitation to participate in the study. Interested participants will complete a baseline questionnaire that will include measures of physical activity (the Godin Leisure-Time Exercise Questionnaire), QoL (Functional Assessment of Cancer Therapy-Breast and Anemia), and social cognitive variables from the theory of planned behavior (based on the guidelines from Ajzen and our previous research). Participants will also wear a pedometer for a 7-day monitoring period to obtain baseline steps. Participants will then be randomized to one of four groups. Depending on randomization, the participants will then receive the appropriate materials. All groups will be recommended to accumulate at least 30 minutes of moderate intensity physical activity at least five days per week which would result in about 15,000 steps per week (or 2,000 steps per day). At the end of the 12-week intervention period, all participants will complete the same post intervention questionnaire and undergo another 7-day monitoring period to obtain step values. Participants will be contacted at 6 months for follow-up and complete the same questionnaire for a final time.
Tipo de estudo
Inscrição
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Alberta
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Edmonton, Alberta, Canadá, T6G 2H9
- University of Alberta, Behavioral Medicine Laboratory
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- histologically confirmed breast cancer.
- mentally competent.
- physician approval to participate in the study.
- free from chronic medical and orthopaedic conditions.
- no current or planned pregnancy.
- ability to read and understand English.
- must be in the post treatment phase of their cancer trajectory.
- willing to accept random assignment.
- not currently participating in another QoL intervention.
- no known or active metastatic disease.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Exercise behavior
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Medidas de resultados secundários
Medida de resultado |
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Qualidade de vida
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Social cognitive determinants of exercise
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kerry S Courneya, PhD, University of Alberta
- Investigador principal: Jeffrey KH Vallance, MA, University of Alberta
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ACTION
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